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ACT to Reduce Morbidity and Mortality in Hematopoietic Stem Cell Transplant (HCT) Patients

NCT04423939 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-11-25

Study results available
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Summary

This is a research study to develop and test a novel protocol to reduce physical and psychological vulnerabilities that contribute to treatment intolerance and treatment-related morbidity and mortality among hematopoietic stem cell transplant (HCT) patients. When the participant enrolls in this study, they will be asked to participate in acceptance and commitment therapy (ACT) as well as complete in-person physical function tests and a cognitive test. They will also receive training on how to use iOS devices (e.g. iPad, iPhone) and activity trackers (e.g. Apple Watch), which will be provided to them during the duration of study participation. The study team will ask you to complete multiple surveys about emotional and cognitive function, diet and social support, and ask the participant to provide feedback about the treatment (e.g., what they liked or did not like). The study team will also ask the participant to provide stool samples for analysis of the bacteria in intestines, skin surface swabs for analysis of the bacteria on skin and blood samples for analysis of biomarkers and metabolites. Biomarkers and metabolites are molecular and cellular parts that deal with genetic makeup, like DNA, RNA, protein, and/or other naturally occurring substances that may be associated with transplant outcomes. Participants can expect to be enrolled in this study for 3 years.

Conditions

  • Hematopoietic Steam Cell Transplantation (HCT)

Interventions

BEHAVIORAL

Acceptance and Commitment Therapy (ACT)

The ACT sessions will be tailored to the clinical challenges of HCT. Sessions are with a mental health professional and are 45-60 minutes in duration and include both the participant and caregiver.

Sponsors & Collaborators

Principal Investigators

  • Anthony Sung, MD · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-14
Primary Completion
2022-05-19
Completion
2025-02-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04423939 on ClinicalTrials.gov